US9155734B2ActiveUtilityA1
Stability of hydromorphone hydrochloride solutions
Est. expiryMar 7, 2032(~5.7 yrs left)· nominal 20-yr term from priority
A61P 25/04A61K 9/08A61K 31/485A61K 9/0085A61K 9/0019
80
PatentIndex Score
4
Cited by
64
References
8
Claims
Abstract
The present invention relates generally to a sterile hydromorphone hydrochloride solution that is substantially free of buffer.
Claims
exact text as granted — not AI-modifiedWhat is claimed is:
1. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 25° C. and 60% relative humidity for at least 3 months.
2. The composition as recited in claim 1 , wherein said composition is suitable for intrathecal delivery.
3. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 30° C. and 65% relative humidity for at least 3 months.
4. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 40° C. and 75% relative humidity for at least 3 months.
5. The composition as recited in claim 1 , wherein said composition is sterilized via aseptic processing.
6. The composition as recited in claim 1 , having a liquid drug formulation wherein the concentration of hydromorphone hydrochloride is about 10.0 mg/mL.
7. The composition as recited in claim 1 , having a liquid drug formulation wherein the concentration of hydromorphone hydrochloride is about 2.0 mg/mL.
8. A method of treating pain, the method comprising: intrathecal delivery of the pharmaceutical composition of claim 1 to a patient.Cited by (0)
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